Tobacco Documents Online

0 11 Fi)A hae acknowledged in the May 15 consent agreement that Sporicidin as manufactured for years is quite OK, and the fine print of the consent agreement provides that axisting stocks will be allowed onto the market again chemically unchanged. Production will resume using exactly the same constituents. The disinfectants will hv exactly the same as before. So what is this "reconditioning" that the FDA is requiring? The word "recurtditioning" is being used by the FDA solely to dascrihe the insertion of an extra instruction sheet in the packaging. This misleading language is part of the PDA's cover up uf itb backdown. It is an attempt to mislead people tntn thinking that the agency forced the company to change its product, when in fact the agency has backed down and acceptetl the prutiuct unchanged. The other face-savar for the FDA is contained in a legal maneuver by which the agency has permitted Sporicidin products back un the market not by approving them but by a "finding of substantial equivalence" to products marketed by the company prior to enactment of the law under which it claiuis jurisdiction. In fact the products are identical. They haven't changed _ and such a 'grandfathering' is simply a way for the FDA to avoid saying ' explidtly that it has approvetl thent. A lPttor from the FDA to Sporicidin dated September 15 spells this out: "This letter will immediately allow yuu to begin (It began in 1975. The FDA writer means: 'resume' P.S.) markating your devices (disinfectant solutions - P.S.) in accordance with the terms of the consent decree. An FDA fuiding of substantial equivalence of your devices (disinfectants N.S.) to a pre- Amendment device (disinfectant P.S.) results in a classification (approval P.S.) of your devices (disinfectants P.S.) and pennits your devices (disinfectants P.S.) to proceed to the market, but it does not mean the FDA has~ approved your devices (disinfectauts) "~ -ir a ~q Q~d.t w b m/lie (~) Such Orwellian verbal contortions anstic sleights-of-han ld cannot cover up the simple fact that the e,autct saine ytvducts which FDA said had to be immediately banned as a monace to health last December 13 are okay as of September 15 this year to go back oz~market unchanged. At time of writing the EPA Is still holding out on Sportcidin with some bi2arre maneuvers of its own. Its many pre-Decembcr 13, 1991 approvals of Sporicidin products have remained in effect throughout the assault on tha company even though the EPA joined the FDA in issuing an N • emergency Stop Sale, Use and Removal Order Deceutlrer 13, 1991 because of a 4~h ~ A .fa ® Cn ta

12 . the supposed inuniuent risks that had been demonstrated in thv NI7A test. The F.PA is now offering to lift this freeze on Sporicidin's cold sterilizing solution but only on condition that SpuriLidirt do its own laboratory testing on the product to demnnstratp its efficacy. But it was the supposed inefficacy of the product as suggested by FDA tests that led to the Deceutber 13 1991 bans. So we have reached the situation where the FDA has allowed products back on the market which David Kessler said last year "don't work." The old AOAC test is disnmdited and there is no generally accepted test to demonstrate spnre killing power. But Sproricidin is being asked by the EPA to devise a new test which will be aLceptable to it. But wait! T'hn N.1JA already has research contracts out with the Canadians for an improved test, and estimates it will be another two to three years before that new test protocol for spore killing is completed. EPA wants a small private company to finance n competitive researdi project fur a uew spuricidal test protocol while fts products remain banned on the basis of the discredited test. "Only in Attterica!" say its international competitors. Sporiddin estimates itc losses to the end of July at the hands of Washington's blundering hiimen at nture than $10 million -- $5 million in lost sales, $2m in custnmer reimbursements, over $1m in legal fees and $2m in lost inventory. 30 people in the manufacturing plant lust their jobs and a dozen administrative and sales people have gone. In their place a team of lawyersl What's behind this destructive madness on the part of regulators? Several agencies fighting for regulatory turf; an effort to 'get' a little upstart company that has upset the established players; a drive by regulators to get scalps on the wall to justify their budget claims in Congress; the huge ego of the likes of PDA administrator D. Kesslet) just normal Washington blundering. Perhaps iYs a hit of all of these. ends Peter Samuel runs Greentrack International, a Washingtnn UC' area news service that Lovers environmental issues from a skeptical perspective. Pnds all 3Mout3/9/23/92 N O V ~ A P O N A